Designation: Sr. Research scientist – AD/Research Scientist- Extended Release/ NDDS

Qualification: M.Sc. (Chemistry / Analytical Chemistry / Pharmaceutical Chemistry or relevant discipline)

Experience: 10–12 Years

Key Responsibilities:

- Execute analytical method development, validation, verification, transfer, and troubleshooting activities for API & pharmaceutical products.
- Provide analytical support for solid oral dosage forms (tablets, capsules) and injectable formulations, with strong expertise in extended-release, sustained-release, and delayed-release products.
- Review and approve analytical protocols, reports, specifications, stability data, and regulatory submissions.
- Ensure compliance with cGMP, GLP, ICH, USP, EP, IP, and other applicable regulatory requirements.
- Support product development, scale-up, exhibit batch analysis, process validation, and commercial manufacturing activities.
- Handle deviations, CAPA, change controls, and laboratory investigations.
- Manage stability studies and trending of analytical data.
- Coordinate with cross-functional teams including R&D;, QA, Regulatory Affairs, Production,



and Technology Transfer.
- Internal audit preparation, encourage team members while driving continuous improvement initiatives for departments, and organization.

- Required Expertise:

- Solid hands-on experience in HPLC, UPLC, GC/GCHS, Dissolution, UV-Vis, FTIR, and other analytical techniques.
- Proven expertise in analytical challenges associated with modified-release formulations (Extended Release/Sustained Release/Delayed Release) and sterile injectable products.
- Sound knowledge of ICH guidelines, pharmacopeial requirements, method lifecycle management, and data integrity principles.
- Experience in regulatory filing support for international markets e.g. US and Europe

Key Competencies:

- Strong "Can-Do" and "To-Do" attitude
- High level of ownership and accountability in delivering results within timelines
- Analytical problem-solving
- Compliance in day-to-day activities
- Effective and continuous communication within the department and other stakeholders

📌 Sr. Research scientist – AD/Extended Release/ NDDS (Karamba)
🏢 Felix Pharmaceuticals
📍 Karamba